(62 days)
Not Found
No
The device description and intended use focus on a mechanical fascial expander prosthesis and do not mention any AI or ML components or functionalities.
Yes
The device is described as a 'fascia expander prosthesis' used for temporary closure of the abdominal cavity in life-threatening conditions. Its purpose is to manage severe abdominal pathology, prevent perfusion impairment, and repeatedly access the abdomen for control and repair, which directly impacts a patient's health and recovery.
No
The device description clearly states that the Wittmann Patch is an adjustable fascial expander prosthesis for temporary bridging abdominal wall incisions. Its purpose is to physically close the abdominal cavity when primary closure is not possible, allowing for repeated access and protecting organs. It does not perform any diagnostic function such as identifying, assessing, or monitoring medical conditions.
No
The device description clearly details a physical medical device consisting of two sheets of biocompatible polymeric material with hook and loop structures, intended for surgical implantation. It does not describe software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a "fascial expander prosthesis" used for "temporarily bridging abdominal wall incisions." It is a physical device implanted to manage a surgical wound and facilitate future surgical access.
- Lack of Specimen Analysis: There is no mention of the device interacting with or analyzing any biological specimens from the patient. Its function is purely mechanical and structural.
- Intended Use: The intended use focuses on surgical management of abdominal pathology and wound closure, not on diagnostic testing.
Therefore, the device described is a surgical implant/device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
It is intended to use the device:
- Advanced intra-abdominal pathology requiring more than one abdominal 1) operation to control the disease. As fascia expander prosthesis to temporarily close the abdominal cavity when regular abdominal closure is not possible because abdominal organs protrude due to massive swelling of tissues, e.g. abdominal compartment syndrome and other severe and life threatening abdominal pathology.
-
- To prevent perfusion impairment of abdominal organs from increased intraabdominal pressure.
-
- Advanced intra-abdominal pathology requiring more than one abdominal operation to control the disease process.
Product codes (comma separated list FDA assigned to the subject device)
FTL
Device Description
Like the predicate devices the Wittmann Patch is adjustable fascial expander prosthesis for temporary bridging abdominal wall incisions where primary closure is not possible and/or repeat abdominal entries are necessary. The device is used in life threatening conditions such as severe abdominal trauma and intra-abdominal infection with and without abdominal compartment syndrome to enable temporary closure of the incised abdominal cavity when direct fascial closure is not possible and would compromise perfusion of intra-abdominal orqans. After 3-5 days use WP is usually no longer required and removed for final abdominal closure without any mesh in place
The device consists of two adhering sheets of biocompatible polymeric material. One sheet bears small hook like structures and the other a meshwork of loops. The two sheets are sutured to opposing fascial edges of an abdominal incision. The abdomen can be closed by pressing one sheet onto the other expanding the fascia prosthesis) to account for increased intraabdominal volume but at the same time it can be easily opened to inspect, control, and repair intraabdominal pathology. The artificial bur fascia provides a temporary safe fascial closure of the abdominal cavity. Once the intraabdominal pathology improves and swelling diminishes it is possible to re-approximate opposing fascias remove the artificial and close the abdominal wound by final fascia-to-fascia suture.
Like the predicate devices the Wittmann Patch consists of two sheets of knitted synthetic fibers with clinging elements on one surface which adhere to each other. The two thin mating meshes are equipped with either loops or hooks respectively. Both sheets are white measuring 20 cm x 40 cm each, and consist of woven polyamide fibers and an additional reinforced backing for the hook sheet.
The two sheets adhere to each other when pressed onto the other. High tangential shearing forces are required to separate the two sheets. Testing has demonstrated that separation of the two sheets would occur only with forces greater than those that would disrupt normal, intact fascia [Wittmann, DH, et al Eur J Surg, 159: 75-79, 1993.]. Peeling the top sheet away from the lower sheet opens the two sheets to access the abdominal cavity.
No component of the final device can be identified that is potentially toxic, carcinogenic or immunogenic (e.g., organic solvents, heavy metals, cross-linking reagents).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Abdominal cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
This 512 (k) application is based on the same clinical and non-clinical performance data as the predicate devices and the same conclusions are drawn and demonstrate that the device is as safe, as effective, and performs as well as or better than the predicate device . 807.92(b) (3)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.
0
APERTA, LLC
093166
Page
510(k) Summary
As required by section 807.92(c).
DEC .
Proprietary name:
WITTMANN PATCH
Common name:
ARTIFICIAL BUR FASCIA PROSTHESIS
SURGICAL MESH Classification name:
Predicate Devices:
We claim equivalence [807.92(a) (3)] with legally marketed devices:
-
- In the United States: "STAR TEMPORARY WOUND COVER" (Trade name: WITTMANN PATCH) permitted for Osteogenics, Inc. on 11/18/1999 with the 510(k) approval Number K983753
-
- in Europe) CE marketed product: ARTIFICIAL BUR FOR TEMPORARY ABDOMINAL CLOSURE (Trade name: WITTMANN PATCH) permitted for HIDIH-Surgical, Schloss Str. 13, D-55444 Dörrebach by TÜV Rhineland Product Safety GmbH for European Community authorities, Permission Number DD 600009914 001 and certificate number SX 600009921 0001
1
APERTA, LLC
K093166
page 2/3
510(k) Summary
As required by section 807.92(c).
Description of the device
Like the predicate devices the Wittmann Patch is adjustable fascial expander prosthesis for temporary bridging abdominal wall incisions where primary closure is not possible and/or repeat abdominal entries are necessary. The device is used in life threatening conditions such as severe abdominal trauma and intra-abdominal infection with and without abdominal compartment syndrome to enable temporary closure of the incised abdominal cavity when direct fascial closure is not possible and would compromise perfusion of intra-abdominal orqans. After 3-5 days use WP is usually no longer required and removed for final abdominal closure without any mesh in place
The device consists of two adhering sheets of biocompatible polymeric material. One sheet bears small hook like structures and the other a meshwork of loops. The two sheets are sutured to opposing fascial edges of an abdominal incision. The abdomen can be closed by pressing one sheet onto the other expanding the fascia prosthesis) to account for increased intraabdominal volume but at the same time it can be easily opened to inspect, control, and repair intraabdominal pathology. The artificial bur fascia provides a temporary safe fascial closure of the abdominal cavity. Once the intraabdominal pathology improves and swelling diminishes it is possible to re-approximate opposing fascias remove the artificial and close the abdominal wound by final fascia-to-fascia suture.
Specification of all material components of the device
Like the predicate devices the Wittmann Patch consists of two sheets of knitted synthetic fibers with clinging elements on one surface which adhere to each other. The two thin mating meshes are equipped with either loops or hooks respectively. Both sheets are white measuring 20 cm x 40 cm each, and consist of woven polyamide fibers and an additional reinforced backing for the hook sheet.
The two sheets adhere to each other when pressed onto the other. High tangential shearing forces are required to separate the two sheets. Testing has demonstrated that separation of the two sheets would occur only with forces greater than those that would disrupt normal, intact fascia [Wittmann, DH, et al Eur J Surg, 159: 75-79, 1993.]. Peeling the top sheet away from the lower sheet opens the two sheets to access the abdominal cavity.
No component of the final device can be identified that is potentially toxic, carcinogenic or immunogenic (e.g., organic solvents, heavy metals, cross-linking reagents).
2
APÉRTA, LLC
K093166
page 3/3
510(k) Summary
As required by section 807.92(c).
Indications
-
- Advanced intra-abdominal pathology requiring more than one abdominal operation.
-
- As fascia expander prosthesis to temporarily close the abdominal cavity when regular abdominal closure is not possible because abdominal organs protrude due to massive swelling of tissues, e.g. abdominal compartment syndrome and other severe and life threatening abdominal pathology.
-
- To prevent perfusion impairment of abdominal organs from increased intraabdominal pressure.
Contraindications
Like the predicate device the Wittmann Patch is not designed or intended for use as a permanent implant. It has not been approved for use in more than five abdominal entries.
Warnings & Limitations
Like the predicate device the Wittmann Patch was not designed to be used as permanent implant. It is for single use only. This device can be sold only to, by, or on the order of a physician.
Non-clinical and clinical performance data
This 512 (k) application is based on the same clinical and non-clinical performance data as the predicate devices and the same conclusions are drawn and demonstrate that the device is as safe, as effective, and performs as well as or better than the predicate device . 807.92(b) (3)
3
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
APERTA, LLC % Dietmar H. Wittmann, MD, PhD 990 Gulf Winds Way Casey Key Nokomis, Florida 34275
Re: K093166
Trade/Device Name: Wittmann Patch Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL Dated: September 18, 2009 Received: October 6, 2009
DEC - 7 2009
Dear Dr. Wittmann:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 - Dietmar H. Wittmann, MD, PhD
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours, Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name:
Wittmann Patch
It is intended to use the device:
- Advanced intra-abdominal pathology requiring more than one abdominal 1) operation to control the disease. As fascia expander prosthesis to temporarily close the abdominal cavity when regular abdominal closure is not possible because abdominal organs protrude due to massive swelling of tissues, e.g. abdominal compartment syndrome and other severe and life threatening abdominal pathology.
-
- To prevent perfusion impairment of abdominal organs from increased intraabdominal pressure.
-
- Advanced intra-abdominal pathology requiring more than one abdominal operation to control the disease process.
Prescription Use X _
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Daniel Kurefai mx4
(Division Sign-Off)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number KL093166